Safe Sedation
Practice for Healthcare
Procedures
Standards and Guidance
October 2013
Academy of
Medical Royal
Colleges
Contents
2
Executive Summary
4
Working Party Members
5Introduction
6
Background to Implementing and Ensuring Safe Sedation Practice for
Healthcare Procedures in Adults 20011
7
What has changed in the last 12 years?
10 Definitions – what is sedation?
12 Practical components of good sedation practice
12 The target state
13Pre-assessment
13 Information and consent
14Fasting
15 Patient management and choice of technique for conscious sedation
15 Titration to effect
16 Multiple drugs and anaesthetic drugs/infusions
18 Use of antagonist drugs
18 Extremes of age – the very young, the elderly and frail, or at-risk patient
19 Monitoring and the use of supplementary oxygen
20 The team and the role of the operator-sedationist
21 Factors supporting the case for dedicated sedationists
22Discharge
22 Record keeping
22 Audit and quality assurance
23 Sedation within an institution: the Sedation Committee
24 Educational and training standards
28 Supplementary doses of opioids
28Setting
29References
32 Appendix 1: Exemplar core curriculum for the safe use of conscious
sedation
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Executive Summary
Sedation is ubiquitous in clinical practice. Avoidable morbidity and mortality continue
to happen despite multiple sets of recommendations and much research.
In 2001 the Academy of Medical Royal Colleges published guidance.1 Since then,
sedation and clinical procedures have evolved whilst the population of patients for
sedation has aged and become frailer with more co-morbidities. Individual specialties
have developed guidance on sedation and there has been some improvement in
training and practice.
Research and audit have identified continued avoidable morbidity and mortality
from sedation. The single most common recurring theme is the lack of formal
training for the appropriate administration of sedative drugs and prompt recognition
and treatment of sedation-related complications. This must be addressed. It is
only through the insistence on formal accredited competency-based training for
all healthcare workers using such techniques, that we can improve the safety of
sedation practice.
This report defines Fundamental Standards and Development Standards in safe
sedation practice and recommends competency-based formal training for all
healthcare professionals involved in sedation. It is the recommendation of this
document that:
■■
Safety will be optimised only if practitioners use defined methods of sedation for
which they have received formal training. Irrespective of educational background,
the competencies required for safe sedation and, crucially, rescue from sedationrelated adverse events, must be the same. There must be one standard for all,
but the educational requirements and pathways to attain a common standard will
vary for different disciplines. It is the responsibility of all disciplines using sedation
techniques to ensure that their trainees receive accredited training in the use of
these techniques, to a clearly defined national standard.
■■
Royal Colleges and associated organisations should define safe sedation
techniques (including the human and equipment resources required) for each
specialty. Addressing the training needs requires that the necessary competencies
for the safe and appropriate administration of sedation and prompt recognition
and treatment of sedation-related complications, be defined and specified within
approved postgraduate training curricula. Trainees who will be expected to use
conscious sedation techniques within their sphere of practice on obtaining their
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Certificate of Completion of Training (CCT), must demonstrate acquisition of the
necessary competencies at Annual Review of Competency Progression (ARCP), or
through an equivalent process.
■■
Those continuing to be actively involved in administering sedation must be able
to demonstrate continued competency through maintenance of an appropriate
level of experience, and ongoing participation in relevant life-long learning/CPD
programmes, now necessary for revalidation.
■■
There should be audit of the process and outcome of procedures performed under
sedation, particularly the incidence of major complications (e.g. cardiopulmonary
arrest, unexpected admission to intensive care and delayed hospital discharge).
■■
To ensure appropriate governance of sedation within an institution a Sedation
Committee should be established to lead and support implementation of these
recommendations at hospital level. This committee should include representatives
from key clinical teams using procedural sedation and there should be a nominated
lead clinician for sedation. In larger institutions, the Sedation Committee should
include an anaesthetist.
■■
To achieve a safe and effective sedation service ‘on the ground’ across clinical
specialties, the concept of a Sedation Team has been developed. The proposed
Sedation Team would have both a practical and an educational role, working
across an institution to support multidisciplinary staff with both continuing
education and ‘hands-on’ clinical expertise. The Sedation Team would have a role
analogous to a pain team, with the aim of improving clinical standards, clinical
effectiveness and the quality of patient care in procedural sedation.
■■
Those responsible for commissioning healthcare in the primary and private sectors
should ensure that similar processes are in place to ensure a safe standard of
sedation practice.
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Working Party Members
The membership of the core group comprised of:
Professor Robert Sneyd Professor Jonathan Benger
Dr Mike Blayney Dr Stephen Furniss
Dr Christopher Holden
Professor Richard Ibbetson
Dr Gavin Lloyd
Dr Alistair McNair
Dr Neil Morton
Dr Ian Parkinson
Dr Anna-Maria Rollin
Professor Andrew Smith
Dr Simon Utting
Mr David Weatherill
Miss Hollie Brennan
Chairman, Royal College of Anaesthetists
College of Emergency Medicine
Royal College of Anaesthetists
Heart Rhythm UK
Society for the Advancement of Anaesthesia in Dentistry
Royal College of Surgeons of Edinburgh
College of Emergency Medicine
British Society of Gastroenterology
Association of Paediatric Anaesthetists
Lancaster Patient Safety Research Unit
Royal College of Anaesthetists
Lancaster Patient Safety Research Unit
British Dental Association
Lay Representative, Royal College of Anaesthetists
Secretary
The following organisations were invited to comment on the guideline throughout the
drafting process:
Association of Dental Anaesthetists
British Ophthalmic Anaesthesia Society
British Pain Society
British Thoracic Society
College of Paramedics
Dental Sedation Teachers Group
Faculty of Dental Surgery, RCS(Eng)
Faculty of General Dental Practice,
RCS(Eng)
Faculty of Intensive Care Medicine
Faculty of Pre-Hospital Care
Intensive Care Society
National Confidential Enquiry into
Patient Outcomes and Death
National Institute of Health and Clinical
Excellence
Resuscitation Council (UK)
Royal College of General Practitioners
Royal College of Nursing
Royal College of Obstetricians and
Gynaecologists
Royal Society of Medicine – Section
of Anaesthesia
Scottish Dental Clinical Effectiveness
Programme
Royal College of Midwives
Royal College of Radiologists
Royal College of Paediatric and Child
Health
Royal College of Physcians
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Introduction
By relieving anxiety, reducing pain and providing amnesia, sedation techniques have
the potential to render uncomfortable diagnostic and therapeutic procedures more
acceptable for patients. However, it must be accepted that these techniques also have
the potential to cause life-threatening complications.
Despite a number of authoritative publications describing the principles of safe
sedation practice, problems continue to occur and relate principally to a failure to
ensure adequate standards of training and practice.
This document makes recommendations to support formal competency-based
training for healthcare professionals wishing to use conscious sedation techniques for
diagnostic and therapeutic procedures.
This document supercedes the previous Academy publication, Implementing and
ensuring safe sedation practice for healthcare procedures in adults.1
This report should be regarded as a baseline for all forms of sedation in all areas of
practice, including the sedation of children. The Francis Report² defines an integrated
hierarchy of standards. Fundamental Standards need to be applied by all those who
work and serve in the healthcare system. No provider should provide any service that
does not comply with these Fundamental Standards, in relation to which there should
be zero tolerance of breaches.
This document sets Fundamental Standards in sedation practice. Francis also defines
Enhanced Quality and Developmental Standards. This document identifies some
practices as Developmental Standards which set longer term goals for providers to
improve effectiveness.
Individual specialist groups may usefully specify additional standards for specific areas
of practice, however these standards should always be additive to and never subtract
from the Fundamental Standards set out here.
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Background to Implementing and Ensuring
Safe Sedation Practice for Healthcare
Procedures in Adults 20011
Past publications have demonstrated a worrying incidence of sedation-related
adverse events, principally in relation to gastrointestinal endoscopic practice.3–4
Having undertaken a prospective audit of upper gastrointestinal endoscopy in two
regions of England, Quine et al demonstrated a 30-day morbidity and mortality of
1:200 and 1:2000, respectively,4 arguably one third of the deaths being attributable
to inappropriate use of sedation. Cardiopulmonary problems were most prevalent,
particularly in the elderly, frail patient. Areas of concern included:
■■
inadequate pre-sedation assessment
■■
inadequate monitoring of patients undergoing sedation
■■
excessive doses in the elderly/frail patient
■■
failure to titrate drugs to effect
■■
lack of appreciation of the risks implicit in the use of drug combinations, e.g.
synergism
■■
association of the use of flumazenil, a benzodiazepine antagonist, with the use of
excessive doses of benzodiazepine and the lack of, or poor, recovery facilities
■■
minimal training of those administering sedation and the lack of supervision of
inexperienced trainees
Although the above summary of problems relates to GI sedation, similar
considerations apply to other areas of sedation practice.
Responding to these concerns in 2001 the Academy of Medical Royal Colleges
published Implementing and ensuring safe sedation practice for healthcare
procedures in adults1, making the key point that safety will be optimised only if
practitioners use defined methods of sedation for which they have received formal
training. The working party recommended a number of new measures to improve
standards of practice and patient safety, and these are listed below:
1 Royal Colleges, in association with the relevant sub-specialty organisations, should
develop guidelines on sedation methods appropriate to clinical practice in their
sphere of influence.
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2 Royal Colleges and their Faculties should incorporate the necessary instruction and
assessment into training and revalidation programmes of those specialties that
use sedation techniques.
3 The clinical governance framework should deliver safe sedation practice at
hospital level by enabling a patient-centred culture in which:
a multidisciplinary team training ensures that all staff understand their roles
b those who actually administer sedative drugs are aware of the possible
adverse consequences and are able to deal with these; and
c audit of adverse incidents, complications (particularly severe ones such
as [cardiovascular or respiratory complications requiring] admission to
intensive care) and adherence to agreed national and local protocols promote
continuous quality improvement.
4 NHS Trusts should apply to sedation techniques the standard of the Clinical
Negligence Scheme which requires that all medical and dental staff in training
be, on appointment, competent in the technical skills and specified tasks
expected of them.
5 Each hospital should nominate two consultants, one an anaesthetist and the other
a user of sedation, to collaborate in the local implementation of guidelines and the
provision of a specialist service for patients with particular problems.
6 Those responsible for commissioning and providing healthcare in the primary and
private sectors should ensure that similar processes are in place to ensure a high
standard of sedation practice.
What has changed in the last 12 years?
In response, the Dental Profession, British Society of Gastroenterology (BSG) and the
Royal College of Radiologists published appropriate guidance aimed at improving
standards of training and practice.5–7 However, concerns over safety remain and
further recommendations have been made to promote safe practice.
In 2004 the National Confidential Enquiry into Patient Outcome and Death (NCEPOD)
published Scoping our Practice.8 This inquiry reviewed 30-day mortality over a
12-month period associated with gastrointestinal endoscopy. Seventy-nine percent of
those patients who died (1,818) had received some form of sedation.
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Sedation was considered inappropriate in 14% of cases, excessive doses of sedative
drugs and the use of drug combinations, particularly in the elderly, being identified
as issues. Reversal of sedation was used in 14% of cases, almost universally, to
counteract unanticipated central nervous system depression (i.e. an overdose). The
reason so many needed reversal of sedation appeared to be due to poor recognition
by the endoscopists of how sensitive those with co-morbidity can be to the effects
of sedatives and giving patients a ‘standard’ dose of sedation, most commonly IV
midazolam 5mg, which was clearly too much for many. Inadequate pre-assessment
was also highlighted as a problem.
Shortfalls in training were identified, only 47% of those endoscopists having
admitted to having attended ‘courses’ on safe sedation. NCEPOD commented that
it is ‘ultimately the responsibility of the person providing sedation to ensure that they
have training in sedation and know the risks and how to respond to them’ . NCEPOD
recommended that all those responsible for administration of sedation should have
received formal training and assessment.8
In dentistry the General Dental Council continues to require registrants wishing to use
sedation to receive appropriate supervised theoretical, practical and clinical training.5,9
In 2008 the National Patient Safety Agency (NPSA) published a Rapid Response
Report entitled Reducing the risk of overdose with midazolam injection in adults,10
stating that some adult patients are being overdosed with midazolam injection when
used for conscious sedation.
Concerns included:
■■
That the dose often exceeded that required.
■■
That the sedative drug is often not titrated to the patient’s individual needs.
■■
Failure to take into account any concurrent medication, e.g. opioids.
■■
Failure to acknowledge that many patients fall into ‘high risk’ categories, for
example, the frail and the elderly.
■■
The frequent reliance on flumazenil for reversal of sedation in patients who have
been over-sedated.
■■
The availability of high strength midazolam presentations resulting in overdose.
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Recommended actions were:
■■
The use of low strength midazolam (1mg/ml in 2ml or 5ml ampoules).
■■
Review of therapeutic protocols to ensure that guidance on use of midazolam is
clear and that the risks, particularly for the elderly or frail, are fully assessed.
■■
Ensuring that all healthcare practitioners participating in sedation techniques have
the necessary knowledge, skills and competences required.
■■
Ensuring that stocks of flumazenil are available where midazolam is used
and that the use of flumazenil is regularly audited as a marker of excessive
dosing of midazolam.
■■
Ensuring that sedation is covered by organisational policy and that overall
responsibility is assigned to a senior clinician which, in most cases, will
be an anaesthetist.
2010 saw the publication of cross-specialty sedation guidance from NICE in relation
to children and young people.11 In addition the Royal College of Surgeons of England,
the College of Emergency Medicine, Department of Health, specialist societies and
independent expert groups have developed guidance documents.12–15
It is encouraging that, following the publication of a number of guidelines making
recommendations for improved standards of training and practice, progress, in some
fields at least, has been made. A national audit of colonoscopy practice undertaken in
2011 has demonstrated significant improvements in sedation practice within the field of
endoscopy. The audit captured data on more than 20,000 colonoscopies over a two-week
period with 94% data capture. Around 90% were performed under conscious sedation and
benzodiazepine and opiate doses were low. Only 0.1% required reversal agents compared
to 14% in the 2004 NCEPOD audit. There was only one death, unrelated to the procedure.16
Nevertheless, there remain concerns about the safety of sedation provision. Recently
the Department of Health identified overdose of midazolam during conscious
sedation as one of the Top Ten ‘Never Events’ for 2012/2013.17
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The principal recurring theme is the lack of formal training for the appropriate
administration of sedative drugs and prompt recognition and treatment of sedationrelated complications. This must be addressed. It is only through insistence on
accredited competency-based training for all healthcare workers using such
techniques that we can improve the safety of sedation practice. Through adequate
formal training and subsequent supervised experience, the competencies required for
safe sedation practice can, and must, be acquired by healthcare professional groups,
including doctors, dentists and nurses, wishing to use sedation. This document
aims to identify the core practical components of good sedation practice and the
competencies required for safe administration of sedative drugs.
Definitions – what is sedation?
Sedation is a drug-induced depression of consciousness, a continuum culminating in
general anaesthesia.
The American Society of Anesthesiologists (ASA) defines three levels of
sedation18 (Table 1).
Minimal sedation is a drug-induced state during which the patient responds normally
to verbal commands. Cognitive function and physical co-ordination may be impaired,
but airway reflexes, and ventilatory and cardiovascular functions are unaffected.
Moderate sedation describes a state where a purposeful response to verbal
commands either alone (~ conscious sedation), or accompanied by light tactile
stimulation, is maintained.
In the United Kingdom Conscious sedation is defined as, ‘a technique in which the
use of a drug or drugs produces a state of depression of the central nervous system
enabling treatment to be carried out, but during which verbal contact with the patient
is maintained throughout the period of sedation. The drugs and techniques used should
carry a margin of safety wide enough to render loss of consciousness unlikely’.1,19 The
endpoint is clearly defined and wide margins of safety stipulated. The airway is
normally unaffected and spontaneous ventilation adequate.
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Deep sedation describes a state where the patient cannot easily be aroused but
responds purposefully to repeated or painful stimulation. It may be accompanied
by clinically significant ventilatory depression. The patient may require assistance
maintaining a patent airway, and positive pressure ventilation.
Table 1 Continuum of depth of sedation: definition of general anaesthesia and levels of
sedation/analgesia (ASA October 2009)18
Minimal Sedation/
Anxiolysis
Moderate Sedation/
Analgesia
(‘Conscious
Sedation’)
Deep Sedation/
Analgesia
Responsiveness
Normal response to
verbal stimulation
Purposeful* response
to verbal or tactile
stimulation
Purposeful* response
following repeated or
painful stimulation
Airway
Unaffected
No intervention
required
Intervention may be
required
Spontaneous
Ventilation
Unaffected
Adequate
May be inadequate
Cardiovascular
function
Unaffected
Usually maintained
Usually maintained
Escalation of required
competencies
* Reflex withdrawal from a painful stimulus is NOT considered a purposeful response. Excerpted
from Continuum of Depth of Sedation. Definition of General Anesthesia and Levels of Sedation/
Analgesia of the American Society of Anesthesiology. From the ASA, 520N, Northwest Highway,
Park Ridge, Illinois, 60068-2573, USA.
In summary, passing along the sedation continuum from minimal through moderate
to deep sedation, and ultimately to general anaesthesia, increasing depression of
physiological systems is seen. The likelihood of adverse events increases, which if
not managed promptly, and effectively, may progress to poor outcomes. Increasing
depth of sedation is, therefore, accompanied by an escalation in the level of
competency required to ensure safe sedation practice, as emphasised by the ASA
position statement shown below:18
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‘Because sedation is a continuum, it is not always possible to predict how an individual
patient will respond. Hence, practitioners intending to produce a given level of sedation
should be able to rescue patients whose level of sedation becomes deeper than initially
intended. Individuals administering Moderate Sedation/Analgesia (‘Conscious Sedation’)
should be able to rescue patients who enter a state of Deep Sedation/Analgesia, whilst
those administering Deep Sedation/Analgesia should be able to rescue patients who
enter a state of General Anesthesia. Rescue of a patient from a deeper level of sedation
than intended is an intervention by a practitioner proficient in airway management and
advanced life support. The qualified practitioner corrects adverse physiologic consequences
of the deeper-than-intended level of sedation (such as hypoventilation, hypoxia and
hypotension) and returns the patient to the originally intended level of sedation.’
If verbal responsiveness is lost the patient requires a level of care identical to that
needed for general anaesthesia.1
Practical components of good
sedation practice
The underlying premise is that safety will be optimised only if practitioners use
defined methods of sedation for which they have received formal training.
The target state
Conscious sedation, achieved through careful titration of drug to effect, is considered
a safe target state because ventilation is normally adequate and cardiovascular
function maintained. However, if verbal responsiveness is lost and the patient
becomes deeply sedated, airway interventions may be required and ventilation may
be inadequate. Consequently deep sedation is considered to require the same level of
care as for general anaesthesia.1
Unless otherwise stated, this document aims to give guidance for the safe use of
conscious sedation techniques by healthcare professionals to facilitate diagnostic
and therapeutic healthcare procedures.
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Pre-assessment
Inadequate pre-assessment is a recurring factor in sedation-related adverse events
and poor outcomes, for all specialties.
Sedation is often administered to sick and/or elderly patients who may have
significant co-morbidity.20–21 Even in younger patients, the presence of heart disease,
cerebrovascular disease, lung disease, liver failure, anaemia, shock and morbid
obesity may indicate dangerous risk factors.6 Hence the importance of pre-operative
assessment and preparation of patients, focusing on medical, social and psychological
assessment and evaluation of risk, taking into consideration the limitations of the
setting, cannot be overestimated.8,22–24
Pre-assessment should, wherever possible, include consultation of previous records.
An important consideration in providing all forms of sedation including conscious/
moderate sedation is the ability to rescue a patient who becomes inadvertently
over-sedated and, where necessary, maintain an airway and establish satisfactory
ventilation and oxygenation. Sedating practitioners should always ask themselves
beforehand ‘Will I be able to ventilate this patient, if necessary?’
Information and consent
Valid consent is an essential preliminary to sedation. Department of Health guidance
is available.25
Information should be provided at an appropriate time (not at the last moment)
when there is a chance to have a discussion and for the patient to be able to ask
questions, understand the choices and risks before making a decision to sedate.
Risks and benefits must be clearly explained and proper distinction should be made
between average risk and personalised risk. Alternatives to sedation (typically general
anaesthesia or local anaesthesia with behavioural techniques) should be clearly
explained. Psychological preparation of patients, especially children and their carers
is an important part of preparation for sedation.
Certain patient groups will require additional bespoke information for example
children, pregnant and lactating women.
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Fasting
Pre-operative fasting for sedation is controversial and considered unnecessary by
some authorities within dentistry and emergency medicine for conscious sedation.5,24
Airway reflexes are assumed to be maintained during moderate and minimal sedation,
and lost during general anaesthesia. It is not clear where the point of loss of reflexes
lies, or if such a point exists. The argument is that using minimal and moderate
sedation, airway reflexes are maintained but this does not consider the potential for
inadvertent over-sedation and the loss of protective airway reflexes.26 In the United
Kingdom the loss of verbal communication/deep sedation is deemed to require the
same level of care as general anaesthesia,1 and many practitioners therefore follow
accepted fasting guidance.27–28
Guidance from NICE on sedation of children11 recommends fasting before sedation
unless the sedation is limited to:
■■
minimal sedation
■■
sedation with nitrous oxide (in oxygen)
■■
moderate sedation during which the child or young person will maintain verbal
contact with the healthcare professional
For elective procedures using any sedation other than the above (and specifically
for deep sedation and moderate sedation during which the child or young person
might not maintain verbal contact with the healthcare professional) the 2-4-6 fasting
rule applies (that is, two hours for clear fluids, four hours for breast milk and six
hours for solids).
For an emergency procedure in a child or young person who has not fasted, the
decision to proceed with sedation should be based on the urgency of the procedure
and the target depth of sedation.
Careful consideration on a case-by-case basis of the patient’s presenting condition,
co-morbidities, the nature of the procedure and the limitations of the environment, is
important to evaluate the risks of aspiration.
Clinicians who choose to sedate patients without fasting should be prepared to justify
this choice.
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Patient management and choice of technique
for conscious sedation
In selecting a suitable technique it should be remembered that the principal aims of
conscious sedation are to:
■■
provide sedation and relieve anxiety
■■
maintain consciousness and patient cooperation
■■
maintain control of physiological parameters
Drugs do not negate the need for good communication skills and a sympathetic
manner. A clear explanation at every stage is essential to reassure the patient,
particularly when sudden movements may compromise the procedure.
No one sedation technique is suitable for all patients or procedures. Adopting the
principle of minimum intervention, the simplest and safest effective technique, based
on patient assessment and clinical need, should be used.
Sedative drugs are usually administered via oral, intravenous or inhalational routes.
Using the intravenous and inhalational routes, the drugs used can, and must, be
titrated to effect (see below). The use of oral sedation may have a limited role.
However, titration to effect with oral dosing is not possible and bioavailability is
variable, resulting in an unpredictable response.
The specific technique used should be defined by a relevant specialty organisation.
Titration to effect
When administering intravenous conscious sedation, the initial drug dose should be
determined by careful pre-assessment of the patient and any relevant history, and this
dose must have taken full effect before any additional dose is given. The use of fixed
doses or boluses is unacceptable. Subsequent doses, if necessary, should be carefully
titrated to achieve the desired effect. Safe sedation demands knowledge of each
drug’s time of onset, peak effect and duration of action. In principle, titrating a drug/
drugs to optimal effect is critical to safely achieving a recognised sedation endpoint,
thereby avoiding inadvertent over-sedation or general anaesthesia.
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Under-sedation is as unwarranted as over-sedation. Where effective sedation cannot
be achieved, despite reasonable doses of hypnotic, consideration should be given
to either abandoning the procedure or progression to general anaesthesia, if the
appropriate staff and other resources are available.
When the intravenous route is used, secure venous access should be maintained
throughout the procedure and into the recovery period, and specific antagonist drugs
(i.e. naloxone and flumazenil) must be to hand.
Careful consideration of the demands of the procedure being undertaken, particularly
whether it is painful or not, is critical to success.
■■
For non-painful procedures sedation alone is sufficient.
■■
Painful procedures require, in addition, the administration of a specific analgesic
agent. It is important to recognise that many sedative and anxiolytic drugs, e.g.
benzodiazepines, possess no analgesic properties and hence their attempted use
to control pain may result in significant overdose. For localised procedures, e.g.
dental or minor procedures, effective local anaesthetic techniques must be used,
once adequate sedation is achieved. For other procedures such as colonoscopy,
systemic analgesia in the form of an opioid may be required. Hence, combinations
of drugs, e.g. sedatives and opioids, may be needed. This combination of drugs
could have a synergistic effect, and increase the depth of sedation.
Multiple drugs and anaesthetic drugs/infusions
As a general rule single drugs are easier to titrate to effect and safer than concurrent
administration of two or more drugs. Drugs in combination typically produce
synergistic effects, have differing times to onset and peak effect and hence may
be unpredictable or difficult to titrate to effect. Safety margins may be narrowed,
increasing the likelihood of overdose, loss of consciousness, respiratory depression
and the need for airway interventions. Where a combination of a benzodiazepine and
an opioid are administered, the opioid should be given first and the benzodiazepine
only given once the peak effect of the opioid is observed. Benzodiazepines may be up
to eight times more potent following prior administration of an opioid and so must be
titrated with care.29
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Multiple drug/anaesthetic drug techniques should only be considered where there is
a clear clinical justification, having excluded simpler techniques. Irrespective of the
setting, where multiple drug/anaesthetic drug techniques are used, the sedation team
should have immediate access to the same range of skills and facilities as would be
found in an acute NHS Trust, for the prompt recognition and immediate management
of adverse events.
Anaesthetic drugs, e.g. propofol, possess a narrow therapeutic index and reduced
margins of safety, increasing the likelihood of adverse events.
In the USA and several European Union (EU) countries, the use of propofol by
non-anaesthetists is described in the literature, although this practice still remains
controversial. European guidelines on the Non-Anaesthetist Administration of
Propofol (NAAP) for endoscopy were published in December 2010.30 They stipulated
stringent regulations and demonstration of clearly defined competencies. A formal
mentored training programme and achieving an appropriate qualification in the
practice was strongly advised and self-training discouraged. Nevertheless, these
guidelines have been rejected by many EU national societies of anaesthesia who
remain clear that only anaesthetists should administer propofol.31 Several randomised
controlled trials have supported the use of propofol by non-anaesthetists in
cardiological and gastroenterology practice. In the UK at present there is no provision
for nationally recognised formal training programmes or qualification in NAAP.32
However, for some procedures, e.g. endoscopic retrograde cholangiopancreatography
(ERCP) and other complex, more prolonged procedures, conscious sedation may
be inadequate, and deeper levels of sedation or even general anaesthesia may be
required to facilitate technical success and ensure patient comfort.32
At this time the administration and monitoring of propofol sedation for such
potentially complex endoscopic procedures should be the responsibility of a dedicated
and appropriately trained anaesthetist.32
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Deep sedation may be accompanied by clinically significant ventilatory depression
and airway interventions may be required to maintain airway patency, and
positive pressure ventilation to correct hypoventilation or apnoea. Individuals
administering deep sedation must be able to rescue patients who become
inadvertently over sedated or enter a state of general anaesthesia. Hence the
administration and monitoring of deep sedation for those procedures requiring
it should be the responsibility of a dedicated sedation-trained anaesthetist, or
alternatively an appropriately trained healthcare professional possessing equivalent
competencies, i.e. those required for the safe administration of deep sedation
and the prompt recognition and rescue management of potential complications,
including general anaesthesia. Such an individual must be proficient in airway
management and life support.
Use of antagonist drugs
The benzodiazepine and opioid antagonists, flumazenil and naloxone, are usually
reserved for emergency use.
The routine use of flumazenil for reversal of sedation with benzodiazepines is not
without potential side effects.10 Incident data suggests that flumazenil is frequently
used to treat inadvertent benzodiazepine overdose and, on occasion, no account
is taken for the shorter half-life of flumazenil, compared to midazolam, leading to
residual re-sedation.10 Recommendations have been made that the use of flumazenil
should be regularly audited as a marker of excessive dosage of midazolam.10,16
Extremes of age – the very young, the elderly
and frail, or at-risk patient
Young children are more sensitive to sedative and opioid drugs than adolescent and
adult patients, and possess physiological and anatomical considerations that demand
supplementary knowledge and skills. Specific training relevant to children is required.
NICE guidance exists for practitioners intending to administer sedation to children
and young people.11
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Elderly patients are more sensitive to many drugs than younger patients. It is well
established that the doses of midazolam and opioid they require is usually half or less
than those required for younger patients. Subsequent incremental doses should also
be reduced. It is important therefore to reduce the dose sufficiently in the elderly, frail
or at-risk patients.20–21
Monitoring and the use of supplementary
oxygen
Clinical and instrumental monitoring to a degree relevant to the patient’s medical
status and the sedation method, must be used.1 Regular communication with the
patient, in addition to putting them at ease, allows monitoring of the level of sedation.
Existing guidance for patients undergoing anaesthesia identifies the need for pulse
oximetry, ECG and automated non-invasive blood pressure monitoring.33 If verbal
communication is lost the patient requires the same level of care as for general
anaesthesia.1 Where conscious sedation is used and continuous verbal contact with
the patient maintained, ECG monitoring is not essential.
Respiratory depression may accompany the use of intravenous sedatives and
opioid analgesic drugs. Oxygen, via nasal cannulae, should usually be administered
from the commencement of sedation, through to readiness for discharge from
recovery, particularly for patients with relevant medical conditions, where multiple
drug techniques or anaesthetic drugs are used, or deeper levels of sedation
administered. Whilst administration of oxygen prevents hypoxia it may mask
hypoventilation. Currently, oxygen administration is not administered in fit patients
undergoing brief, simple procedures and its use in this group should be considered a
Developmental Standard.
The Association of Anaesthetists of Great Britain and Ireland recommend that
continuous waveform capnography should be used to monitor adequacy of ventilation
for all patients undergoing moderate or deep sedation, and should be available
wherever any patients undergoing moderate or deep sedation are recovered34 and
additionally where:
■■
ventilation cannot be directly observed, e.g. MRI/CT
■■
multiple drugs/anaesthetic drug techniques are used, and
■■
pre-assessment highlights increased clinical risk.
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Use of capnography was supported in the NAP4 project report ‘Complications of
airway management in the United Kingdom’; this included not only anaesthesia but
also intensive care and the emergency department.35
Where not already in use, as a fundamental standard, capnography for patients
receiving sedation should be considered a Developmental Standard.
Monitoring should be continued into the recovery period.
Checklists are recommended by the World Health Organization to avoid errors in
the surgical process.36 Useful checklists also support procedures for emergencies
including anaphylaxis.37
The use of checklists may contribute to Safe Sedation practice, particularly the
prompt recognition and management of adverse events. The use of checklists for
patients receiving sedation should be considered a Developmental Standard.
The team and the role of the operatorsedationist
The term ‘operator-sedationist’ defines an individual who both administers sedation
and performs the required procedure. However, it may not be possible for an
individual administering the sedation and performing the procedure to be fully
cognisant of the patient’s condition during sedation. It is essential, therefore, that if
this model of care is to be used that an appropriately trained second individual, other
than the person performing the procedure, monitors the patient’s status.
Current guidance for performing gastroenterological procedures under conscious
sedation states that where the gastroenterologist works as an operator-sedationist,
a minimum of two endoscopy assistants, of whom at least one is a qualified nurse, be
present at endoscopy.6 One assistant is dedicated solely to patient care, having a key
role in monitoring the patient’s safety, comfort and well-being and in communicating
significant changes to the endoscopist. All endoscopy assistants must be capable
of helping the endoscopist in the case of emergencies such as cardiac or respiratory
arrest, and adequate training and periodic retraining is required. However, it is
deemed acceptable in some specialties, e.g. dentistry, that, where conscious sedation
is the target state, a second individual already responsible for monitoring the patient
may assist the operator-sedationist with interruptible ancillary tasks of short duration,
no third person being required.5,12
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Factors supporting the case for dedicated
sedationists
■■
The demands of increasingly complex sedation techniques including multiple drug
techniques and anaesthetic drug infusions. Techniques that may demonstrate:
▼▼
synergistic effects (where drug combinations are used)
▼▼
wide inter-individual variation in response, and hence dose regimens
▼▼
unpredictability, where multiple drugs are titrated to effect
▼▼
a narrow therapeutic index and hence an increased potential for over-sedation
and adverse events
■■
More prolonged and more complex procedures are being undertaken under
sedation, for example in gastroenterology and radiology, where deeper
levels of sedation are required to ensure patient comfort and likelihood of
technical success.32
■■
The need to care for an increasing number of elderly, frail patients with multiple
co-morbidities.
■■
The devolution of healthcare to what constitute remote environments.
■■
Current training deficiencies and needs that must be addressed.
Taking these factors into account, for all but brief and simple procedures, undertaken
on fit patients, serious consideration must be given to the use of a trained dedicated
sedationist, whose sole responsibility is to administer sedation, monitor the patient
and address any sedation-related issues. If a dedicated sedationist is not used, the
operator-sedationist must be prepared to justify the decision.
If the operator-sedationist model is to be pursued then the presence of a third
trained person is required for all but the simplest procedures, performed on fit (ASA
1 or 2) patients, thus ensuring that one appropriately trained assistant can give the
patient their undivided attention to monitor their comfort, level of sedation and
physiological parameters.
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Discharge
Patients should be formally assessed for suitability for discharge from the clinical area
where sedation has taken place. Discharge criteria are as follows:15
■■
The patient has returned to their baseline level of consciousness.
■■
Vital signs are within normal limits for that patient.
■■
Respiratory status is not compromised.
■■
Pain and discomfort have been addressed.
■■
If there is a requirement to discharge the patient prior to meeting these
criteria they should be transferred to an appropriate clinical environment with
continuation of peri-procedure monitoring standards.
■■
Patients meeting discharge criteria following sedation who go on to be discharged
home should be discharged into the care of a suitable third party.
■■
Verbal and written instructions should be given.
Record keeping
Patient evaluation, consent, data from monitoring during and after sedation and
readiness for discharge should be documented.
Audit and quality assurance
Sedation within an institution: clinical incident reporting and auditable standards.
As part of a robust risk management strategy, all NHS institutions should now have
computerised incident reporting systems and all clinical incidents where sedation is a
factor should be reported. Midazolam over-sedation is defined as a ‘never event’ by
the Department of Health17 and reporting of these incidents to the National Reporting
and Learning System and to the body commissioning this care is mandatory. Failure
to monitor oxygen saturation during sedation is also a ‘never event’ and should be
reported in this way.
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Clinical incidents that should be reported and investigated locally, within an
institution, include: use of flumazenil to reverse sedation, as a surrogate marker
of midazolam oversedation; use of naloxone to reverse sedation where opiates
have been administered; sustained drop in oxygen saturation <90%; unplanned
instrumentation of the airway or intervention of an anaesthetist or other airway
expert; unplanned admission to hospital following a procedure under sedation.
Each clinical team using sedation within an institution should audit the number of
cases performed by each sedation practitioner and the rate of complications of this
sedation, including the incidents referred to above.
Auditable outcomes include:
■■
number of procedures performed by each operator
■■
unplanned admissions and operations within eight days of procedure
■■
30-day mortality
■■
use of flumazenil
■■
use of naloxone
■■
need for ventilation
■■
sustained drop in O2 saturation <90%
Sedation within an institution: the
Sedation Committee
To ensure appropriate governance of sedation within an institution a Sedation
Committee should be established to lead and support implementation of these
recommendations at hospital level. This committee should include representatives
from key clinical teams using procedural sedation and there should be a nominated
lead clinician for sedation. In larger institutions, the Sedation Committee should
include an anaesthetist.
Suggested duties of the Sedation Committee include development and review of local
guidelines; review of pharmacovigilance of sedative drugs, including midazolam and
flumazenil storage and use; review of reported clinical incidents where sedation is a
factor; annual audit of numbers of sedation cases and the incidence of complications
within the institution; overview of staff training and continuing personal development
in sedation practice.
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To achieve a safe and effective sedation service ‘on the ground’ across clinical
specialties, the concept of a Sedation Team has been developed. The proposed
Sedation Team would have both a practical and an educational role, working across
an institution to support multidisciplinary staff with both continuing education and
‘hands-on’ clinical expertise. The Sedation Team would have a role analogous to a
pain team, with the aim of improving clinical standards, clinical effectiveness and the
quality of patient care in procedural sedation.
Educational and training standards
Safety will be optimised only if practitioners use defined methods of sedation for
which they have received formal training.
Irrespective of educational background, the competencies required for safe sedation
and, crucially, rescue from sedation-related adverse events, must be the same. There
must be one standard for all, but the educational requirements and pathways to attain
a common standard will vary for different disciplines.
Successive publications have highlighted a lack of formal training as contributing to
sedation-related adverse events.1,4,6,8,10 Safe Sedation Practice 2001 called on Royal
Colleges and their Faculties to incorporate the necessary instruction and assessment
into the training and revalidation programmes of those specialties that use sedation
techniques. Lack of formal training remains an important issue.
It is the responsibility of all disciplines using sedation techniques to ensure that their
trainees receive accredited training in the use of these techniques, to a clearly defined
national standard.
Addressing the training needs requires that the necessary competencies for the safe
and appropriate administration of sedation and prompt recognition and treatment
of sedation-related complications, be defined and specified within approved
postgraduate training curricula. Trainees who will be expected to use conscious
sedation techniques within their sphere of practice on obtaining their Certificate
of Completion of Training (CCT), must demonstrate acquisition of the necessary
competencies at Annual Review of Competency Progression (ARCP), or through an
equivalent process.
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Those continuing to be actively involved in administering sedation must be able to
demonstrate continued competency through maintenance of an appropriate level of
experience, and ongoing participation in relevant life-long learning/CPD programmes,
now necessary for revalidation.
A summary denoting the team, skills, monitoring, environment and facilities
relevant to the sedation continuum considered by this group has been included (see
Table 2 opposite).
In addition, the necessary competencies have been defined within an exemplar core
curriculum (see Appendix 1). This exemplar curriculum is based upon competencybased sedation training specified within the basic and intermediate sections of
the CCT in Anaesthetics Training Curriculum, published by the Royal College of
Anaesthetists.38–39 Sedation training may be achieved using alternate competencybased syllabus structures that reflect the Fundamental Standards described in
this report.
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Table 2 Continuum of depth of sedation. A summary of the team, skills, monitoring,
environment and facilities
Minimal
Sedation/
Anxiolysis
Moderate Sedation/Analgesia
(‘Conscious Sedation’)
Deep Sedation/
Analgesia
Responsiveness
Normal
response
to verbal
stimulation
Purposeful* response to verbal or
tactile stimulation
Purposeful*
response following
repeated or painful
stimulation
Airway
Unaffected
No intervention required
Intervention may
be required
Spontaneous
ventilation
Unaffected
Adequate
May be inadequate
Cardiovascular
function
Unaffected
Usually maintained
Usually maintained
N.B. Increasing depth of sedation is accompanied by increasing depression of physiological systems
(CNS, RS, CVS). Sedation is a continuum and it is not always possible to predict how an individual
patient will respond. Practitioners administering sedation, and those tasked with monitoring, must
be trained to promptly recognise and manage patients whose level of sedation becomes deeper than
intended and experience respiratory depression, loss of airway and inadequate ventilation
The team
■■
Operatorsedationist
■■
Appropriate
second
person
1 Brief, simple procedures – a
second individual may suffice to
monitor the patient and assist
the operator-sedationist with
interruptible ancillary tasks of
short duration5,12§
■■
Operator
■■
Dedicated
sedationtrained
anaesthetist or
alternatively an
appropriately
trained
healthcare
professional§§
■■
Trained
assistant
2 For all but brief and simple
procedures a three person model
is advocated:
■■
Operator-sedationist
■■
Trained assistant to monitor
patient
■■
Assistant to procedure
3 For complex or prolonged
procedures or where patient
frailty and significant comorbidities exist, a dedicated
sedationist is required
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Minimal
Sedation/
Anxiolysis
Moderate Sedation/Analgesia
(‘Conscious Sedation’)
Deep Sedation/
Analgesia
Monitoring
Dictated by comorbidity
Verbal responsiveness. SaO2.
NIBP. Use of ECG and ETCO2 are
Developmental Standards and
already recommended by one
authority33–34
Response to
repeated/painful
stimulus, SaO2,
ECG, NIBP, ETCO2
Availability of
resuscitation
skills
BLS – as
defined by
RC(UK)40
ILS – as defined by RC(UK)
ALS – as defined
by RC(UK)
Specific airway
skills required
Basic airway
manoeuvres
Competency in the use of basic airway manoeuvres, airway
adjuncts, supraglottic devices, and bag and mask ventilation
Environment
and facilities
ASA 1 and 2
patients are
suitable for
treatment in
primary and
secondary care
Where anaesthetic drug techniques
(with or without opioid) are
used, trained personnel must be
immediately available to assist with
the resuscitation of a collapsed
patient so that the patient’s airway,
breathing and circulation are
supported fully without delay
NHS Acute
Trust setting or
equivalent**
Notes accompanying Table 2
* Reflex withdrawal from a painful stimulus is NOT considered a purposeful response.
** See page 27.
§ The use of opioid/midazolam combinations for dental procedures. For those patients requiring conscious
sedation for dentistry, the majority of procedures can be undertaken using inhalational sedation (O2/
N2O), or sedation using a benzodiazepine (midazolam) as a single drug. Analgesia for painful procedures
is provided by means of effective local anaesthesia in conjunction with behavioural management
strategies. A small number of patients may require the use of systemic analgesia to facilitate
administration of local anaesthesia, for example, if multi-quadrant dental treatment is planned. For
these patients it may be appropriate to administer a single dose of a short-acting opioid, e.g. fentanyl,
waiting a period of time for it to take full effect and only then titrating midazolam to effect. Due to the
unpredictability of titrating multiple drugs to effect, the addition of a subsequent dose of opioid should
be avoided. There should be no reliance on systemic analgesia to undertake the procedure itself. If the
procedure cannot be undertaken satisfactorily with local analgesia it would be appropriate to abandon
the procedure and consider an alternative technique of pain and anxiety management.
§§ An appropriately trained healthcare professional possessing equivalent competencies, i.e. those required
for the safe administration of deep sedation and the prompt recognition and rescue management of
potential complications, including general anaesthesia. Such an individual must be proficient in airway
management and life support.
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Supplementary doses of opioids
Supplementary doses of opioids may be required in prolonged uncomfortable
procedures such as colonoscopy for which local anaesthesia is not appropriate.
Setting
**It is important to recognise the limitations of working in the relative isolation of the
non-theatre or non-hospital setting.
Irrespective of the setting, where multiple drug/anaesthetic drug techniques are used
to provide conscious sedation, the sedation team should have immediate access to
the same range of skills and facilities as would be found in an acute NHS Trust, for the
prompt recognition and immediate management of adverse events.
Patient selection in advance of the procedure will determine whether the setting
meets the requirements of the patient, intended procedure and proposed sedation
technique. Staffing and equipment must meet the needs of both the technique
(including monitoring) and its possible complications. Appropriate recovery
facilities and discharge criteria relevant to the patient’s destination are necessary.
Resuscitation equipment must be checked, maintained and include all the drugs
necessary for life support.
The management of sedation-related complications and medical emergencies should
be regularly rehearsed as a team.
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References
1 Implementing and ensuring safe sedation practice for healthcare procedures in adults. AoMRC,
London 2001:1–21 (www.rcoa.ac.uk/node/2270).
2 Executive summary of the report of the Mid-Staffordshire NHS Foundation Trust Public Enquiry.
Chaired by Robert Francis QC, February 2013 (www.midstaffspublicinquiry.com/sites/default/files/
report/Executive%20summary.pdf).
3 Daneshmend TK, Bell GD, Logan RF. Sedation for upper gastrointestinal endoscopy: results of a
nationwide survey. Gut 1991;32(1):12–15.
4 Quine MA et al. Prospective audit of upper gastrointestinal endoscopy in two regions of England:
safety, staffing, and sedation methods. Gut 1995;36(3):462–467.
5 Conscious sedation in the provision of dental care. Report of an expert group on sedation for
dentistry. Standing Dental Advisory Committee. DH, London 2003;1:1–36
(http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/
digitalasset/dh_4074705.pdf).
6 Guidelines on safety and sedation during endoscopic procedures. BSG, London 2003 (www.bsg.
org.uk/clinical-guidelines/endoscopy/guidelines-on-safety-and-sedation-during-endoscopicprocedures.html).
7 Safe sedation, analgesia and anaesthesia within the radiology department. RCR, London 2003;1;1–8.
(www.rcr.ac.uk/publications.aspx?PageID=310&PublicationID=186).
8 Scoping our practice. NCEPOD, London 2004 (www.ncepod.org.uk/2004sop.htm).
9 Standards for dental professionals. GDC, London 2005 (www.gdc-uk.org/dentalprofessionals/
standards/pages/default.aspx).
10 Reducing risk of overdose with midazolam injection in adults. Rapid Response
Report (and supporting information). NPSA, London 2008 (www.nrls.npsa.nhs.uk/
resources/?entryid45=59896).
11 Sedation in children and young people: sedation for diagnostic and therapeutic procedures in
children and young people (CG112). NICE, London 2012 (http://publications.nice.org.uk/sedationin-children-and-young-people-cg112).
12 Standards for conscious sedation in dentistry: alternative techniques. A report from the Standing
Committee on Sedation for Dentistry. RCoA and RCS Eng, London 2007 (www.rcoa.ac.uk/
node/2283).
13 Guidelines for the appointment of dentists with a special interest (DwSI) in conscious sedation
(Gateway Ref: 9102). DH and FGDP, London 2007 (www.fgdp.org.uk/_assets/pdf/dentists%20
with%20special%20interests/dwsi_cons_sed.pdf).
14 Conscious sedation in dentistry: standards for postgraduate education. DSTG 2008 (www.dstg.
co.uk/wp-content/uploads/2012/09/dstg-pg-standards.pdf).
15 Safe sedation of adults in the Emergency Department. RCoA and CEM, London 2012 (www.rcoa.
ac.uk/node/10214).
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16 Gavin DR et al. The national colonoscopy audit: a nationwide assessment of the quality and safety
of colonoscopy in the UK. Gut 2013;62(2):242–249.
17 The ‘Never Events’ list 2012/2013. DH, London 2012 (www.gov.uk/government/uploads/system/
uploads/attachment_data/file/142013/Never_events_201213.pdf).
18 Continuum of depth of sedation: definition of general anaesthesia and levels of sedation/analgesia.
ASA, USA 2009 (http://bit.ly/11iGIax).
19 Wylie DWD. The Wylie Report 1978;1:1–21.
20 Gray A, Bell DG. Elderly patients vulnerable because of excessive doses of sedatives. NPSA,
London 2006 (www.ncepod.org.uk/pdf/current/NPSA%20sedation%20article.pdf).
21 Lord DA et al. Sedation for Gastrointestinal Endoscopic Procedures in the Elderly: Getting Safer
but Still Not Nearly Safe Enough. BSG, London 2006;19:1–14 (www.bsg.org.uk/pdf_word_docs/
sedation_elderly.pdf)
22 Bhananker SM et al. Injury and liability associated with monitored anesthesia care. A closed claims
analysis. Anesthesiol 2006;104:228–234.
23 Hug CCJ. MAC should stand for maximum anesthesia caution, not minimal anesthesiology care.
Anesthesiol 2006;104(2):221–223.
24 Thorpe RJ, Benger J. Pre-procedural fasting in emergency sedation. Emerg Med J 2010;27(4):254–
261.
25 Reference guide to consent for examination or treatment. DH, London 2009 (www.gov.uk/
government/uploads/system/uploads/attachment_data/file/138296/dh_103653__1_.pdf).
26 Mulady DK. The effect of intravenously administered diazepam, midazolam and flumazenil on the
sensitivity of upper airway reflexes. Anaesth 1994;49(2):105–110.
27 Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the
risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an
updated report by the American Society of Anesthesiologists Committee on Standards and Practice
Parameters. Anesthesiol 2011; 7(114):495–511.
28 Clinical practice guideline: Perioperative fasting in adults and children (full). RCN, London 2005
(www.rcn.org.uk/__data/assets/pdf_file/0009/78678/002800.pdf).
29 Ben-Schlomo I et al. Midazolam acts synergistically with fentanyl for induction of anaesthesia. Br J
Anaesth 1990;64(1):45–47.
30 Dumonceau JM et al. Non-anaesthesiologist administration of propofol for GI endoscopy. ESGEESGENA-ESA guideline. Endoscopy 2010;42:960–974 (www.esge.com/assets/downloads/pdfs/
guidelines/2010_non_anesthesiologist_admin_propofol_gi_endo.pdf).
31 Perel A. Non-anaesthesiologists should not be allowed to administer propofol for procedural
sedation. EJA 2011;28(8):580–584.
32 Guidance for the use of propofol sedation for adult patients undergoing Endoscopic Retrograde
Cholangiopancreatography (ERCP) and other complex upper GI endoscopic procedures. RCoA and
BSG, London 2011 (www.rcoa.ac.uk/node/2266).
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33 Recommendations for standards of monitoring during anaesthesia and recovery (4th Edition).
AAGBI, London 2007 (www.aagbi.org/sites/default/files/standardsofmonitoring07.pdf).
34 The use of capnography outside the operating theatre. Safety Statement. AAGBI, London 2011
(www.aagbi.org/sites/default/files/Capnographyaagbi090711AJH%5B1%5D_1.pdf).
35 Major complications of airway management in the UK. Results of the 4th National Audit Project
of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and
emergency departments. Br J Anaesth 2011;106(5):632–642.
36 WHO Surgical Safety Check list. January 2009 (www.nrls.npsa.nhs.uk/alerts/?entryid45=59860).
37 Management of a patient with suspected anaphylaxis during anaesthesia. Safety drill. AAGBI,
London 2009 (www.aagbi.org/sites/default/files/ana_web_laminate_final.pdf).
38 CCT in Anaesthetics – Basic Level Training (Annex B). RCoA, London 2010 (www.rcoa.ac.uk/
node/1411).
39 CCT in Anaesthetics – Intermediate Level Training (Annex C). RCoA, London 2010 (www.rcoa.
ac.uk/node/1434).
40 Resuscitation Guidelines. Resuscitation Council (UK), 2010 (www.resus.org.uk/pages/GL2010.pdf).
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Appendix 1: Exemplar core curriculum for the
safe use of conscious sedation
Core curriculum for the safe use of conscious sedation
techniques for diagnostic and therapeutic healthcare procedures
Conscious sedation techniques are increasingly being used to render potentially
uncomfortable diagnostic and therapeutic procedures more pleasant for patients.
Nevertheless, they are not without risk and have the potential to cause lifethreatening complications. It is essential that trainees understand what is meant by
conscious sedation (‘A technique in which the use of a drug or drugs produces a state of
depression of the central nervous system enabling treatment to be carried out, but during
which verbal contact with the patient is maintained throughout the period of sedation’)
and how it is administered safely.
Learning outcomes:
■■
To gain a fundamental understanding of what is meant by conscious sedation and
the risks associated with deeper levels of sedation.
■■
To be able to describe the differences between conscious sedation and deeper levels
of sedation, with its attendant potential risks to patient safety.
■■
To gain a fundamental understanding that loss of verbal responsiveness/deep
sedation requires the same level of skills and care as for general anaesthesia.
■■
To recognise the important principle of minimum intervention, where the simplest
and safest technique which is likely to be effective is used to achieve the clinical goal.
■■
To gain a fundamental understanding of the particular dangers associated with the
use of multiple sedative drugs, especially in the elderly and young children.
■■
To be able to safely deliver pharmacological sedation to appropriate patients and
recognise the limits of their competency and experience.
■■
To be able to discuss where and when deeper levels of sedation or anaesthesia may
be indicated.
■■
To be able to manage sedation-related side effects in a timely manner, ensuring
patient safety is of paramount consideration at all times.
■■
To gain a fundamental understanding that for all but brief and simple procedures,
undertaken on fit patients, serious consideration must be given to the use of a trained
dedicated sedationist, whose sole responsibility is to administer sedation, monitor the
patient and address any sedation-related issues and that if a dedicated sedationist is
not used the operator-sedationist must be prepared to justify the decision.
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Knowledge
Competence
Description
Suggested
Assessment
Methods
GMP
CS_K_01
Can explain:
A,D,E
1,2,3
■■
What is meant by conscious sedation and why
understanding the definition is crucial to patient
safety.
■■
The differences between conscious sedation, deep
sedation and general anaesthesia.
■■
The fundamental differences in techniques/drugs
used/risks to patient safety.
■■
The potential significant risks to patient safety
associated with sedation techniques that requires
meticulous attention to detail by a dedicated suitably
trained sedationist with responsibility for patient
safety, safe monitoring and contemporaneous record
keeping.
CS_K_02
Describes the indications for the use of conscious
sedation.
A,C,E
1,2
CS_K_03
Describes the rationale for the use of single drug, multiple
drug and inhalation techniques.
A,C,E
1,2
CS_K_04
Describes the risks associated with conscious sedation
including [but not exclusively] those affecting the
respiratory and cardiovascular systems.
A,C,E
1,2
CS_K_05
Describes the importance of thorough pre-operative
assessment and preparation of patients, focusing
on medical, social and psychological assessment
and evaluation of risk, taking into consideration the
limitations of the location. This should include being
able to take an appropriate history (e.g. including sleep
apnoea and history of problematic airway management
during anaesthesia).
A,C,E
1,2,3
CS_K_06
Describes the pharmacology of drugs commonly used to
produce sedation and their antagonists.
A,C,E
1
CS_K_07
Explains the need for and means of monitoring the
sedated patient including the use of commonly used
sedation scoring systems.
A,C,E
1,2
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Safe Sedation Practice for Healthcare Procedures
Academy of
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CS_K_08
Describes how drugs should be titrated to effect and how
the use of multiple drugs with synergistic actions can
reduce the therapeutic index and hence the margin of
safety.
A,C,E
1,2
CS_K_09
Describes the importance of considering the demands
of the procedure being undertaken, particularly
whether it is painful or not, in determining the drugs
used, appreciating that painful procedures require the
administration of a specific analgesic agent.
A,C,E
1,2
CS_K_10
Describes the importance of recognising the following
when multiple drug techniques are employed:
A,C,E
1,2,3
■■
Increased potential for adverse outcomes when two
or more sedating/analgesic drugs are administered.
■■
The importance of titrating multiple drugs to effect
whilst recognising that the possibility of differing
times of onset, peak effect and duration, can result in
an unpredictable response.
■■
Knowledge of each drug’s time of onset, peak effect,
duration of action and potential for synergism.
CS_K_11
Discusses the place of infusions compared to bolus doses
of sedative agents.
A,C
1
CS_K_12
Can explain the minimal monitoring required during
pharmacological sedation.
A,C,E
1
CS_K_13
Describes the risks implicit in the administration of
sedative drugs to the elderly frail patient and young
children and how sedation techniques should be modified
accordingly.
A,C,E
1,2,3
CS_K_14
Describes the indications for the use of reversal agents
and potential problems associated with their use.
A,C,E
1,2
CS_K_15
Explains the need for robust recovery and discharge
criteria when conscious sedation is used for out-patient
procedures and the importance of ensuring appropriate
escort arrangements are in place.
A,C,E
1,2,3
34
Standards and Guidance 2013
Academy of
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A,C,E
1,2,3
Explains the need to ensure that, irrespective of the
setting, where multiple drug/anaesthetic drug techniques
are used to provide conscious sedation, the sedation
team should have immediate access to the same range
of skills and facilities as would be found in an acute NHS
trust setting, for the prompt recognition and immediate
management of adverse events.
A,C,E
1,2
Competence
Description
Suggested
Assessment
Method
GMP
CS_S_01
Demonstrates the ability to undertake a thorough
pre-operative assessment, taking into account the
patient’s age, frailty and any significant co-morbidities,
in determining an appropriate management plan and
identifying the ‘at-risk’ patient. This should include airway
assessment, to identify features associated with increased
risk of difficulty maintaining the airway and/or ventilation.
A,C,D
1,2,3
CS_S_02
Demonstrates the ability to recognise limits of their
competency and experience and when to refer patients
for further assessment and possibly the use of an
alternative management technique.
A,C,D
1,2
CS_S_03
Demonstrates the ability to explain sedation to patients
and to obtain consent.
A,D
1,2,3
CS_K_16
CS_K_17
Discusses the limitations imposed by working in the
isolation of the remote/non-hospital environment
including:
■■
The need to ensure that each component of the
premises, e.g. waiting room, surgery, recovery area,
is appropriate to the sedation technique(s) used.
■■
The importance of robust patient selection including
that it be undertaken in advance of actual treatment
and include a valid consent process.
■■
Awareness that staff and equipment available must
meet the needs of both the technique (including
monitoring) and its possible complications;
awareness of the need to ensure that resuscitation
equipment is regularly checked, maintained and
includes all the drugs and equipment necessary for
advanced life support.
Skills
35
Safe Sedation Practice for Healthcare Procedures
Academy of
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CS_S_04
Demonstrates the ability to consider the following when
considering the choice of sedation technique:
■■
That no one technique is suitable for all patients and
that the most appropriate technique is based on the
principal of minimum intervention, using the simplest
and safest effective technique, based on patient
assessment and clinical need.
■■
That techniques using multiple drugs/anaesthetic
drugs should only be considered where there is a
clear clinical justification, having excluded simpler
techniques.
A,C,E
1,2
CS_S_05
Demonstrates the ability to take into consideration the
demands of the procedure being undertaken, particularly
whether it is painful or not, in choosing a suitable
technique.
A,C,E
1,2
CS_S_06
Demonstrates the ability to administer and monitor
inhalational sedation to patients for clinical procedures.
A,D
1,2,3
CS_S_07
Demonstrates the ability to administer and monitor
intravenous sedation to patients for clinical procedures.
A,D
1,2,3
CS_S_08
Demonstrates the ability to select sedation techniques
appropriate to management in patients of all ages,
including those with significant co-morbidities.
A,C
1,2
CS_S_09
Demonstrates the ability to recognise the limitations
of conscious sedation techniques and where and when
deeper levels of sedation or general anaesthesia may be
indicated.
A,C,D
1,2
CS_S_10
Demonstrates the ability to recognise and manage
the complications of sedation techniques promptly
and appropriately, including recognition and correct
management of loss of verbal responsiveness. This
includes the possession of advanced life support skills,
including the management of the unconscious patient
through possession of deployable airway skills, including,
basic airway manoeuvres, use of airway adjuncts, e.g.
oropharyngeal airway, supraglottic devices, e.g. iGel/
LMA, and the ability to administer positive pressure
ventilation (bag-mask-valve ventilation) when indicated.
A,D
1,2,3
36
Standards and Guidance 2013
Academy of
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Assessment Method Decode
A
Anaesthesia Clinical Evaluation Exercise (A-CEX)
C
Case-based discussion (CBD)
D
Direct observation of clinical skills (DOPS)
E
Examination
GMC Domains
Domain 1
Knowledge, skills and performance
Domain 2
Safety and quality
Domain 3
Communication, partnership and teamwork
Domain 4
Maintaining trust
37
Safe Sedation Practice for Healthcare Procedures
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